U.S. Commerce Department Announces Investigation on Medical Imports

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On September 2, 2025, the Secretary of Commerce started an investigation. The investigation will look at how importing personal protective equipment (PPE), medical consumables, and medical equipment, including devices, affects U.S. national security. This investigation is under Section 232 of the Trade Expansion Act of 1962.

The Bureau of Industry and Security (BIS) will run this investigation. They invite the public and interested parties to send in written comments, data, or other information. The deadline to submit comments is October 17, 2025.

What Is Being Investigated?

The investigation covers:

  • PPE used in health care settings, like surgical masks, N95 respirators, gloves, and gowns.
  • Medical consumables, which are single-use or short-term-use items, such as syringes, needles, IV pumps, IV bags, catheters, bandages, gauze, sutures, and laboratory reagents. It does not include pharmaceuticals like drugs, which are part of another investigation.
  • Medical equipment, which means durable equipment and tools, like wheelchairs, hospital beds, and crutches.
  • Medical devices, such as pacemakers, insulin pumps, coronary stents, hearing aids, prosthetics, blood glucose monitors, MRI machines, ventilators, and x-ray machines.

How to Submit Comments

Comments can be sent through the Federal rulemaking portal at www.regulations.gov. The regulations.gov ID is BIS-2025-0258. Use XRIN 0694-XC134 in all comments.

If you send business confidential information, mark those pages “BUSINESS CONFIDENTIAL.” Also give a non-confidential version marked “PUBLIC.” File names should start with “BC” for confidential and “P” for public. Comments sent without these markers will be made public.

Main Issues BIS Wants Comments On

The Department is looking for information especially on:

  • The current and future demand for PPE, medical consumables, and equipment in the U.S.
  • How much domestic production can meet this demand.
  • The role of foreign supply chains, especially major exporters, in supplying these goods.
  • If many U.S. imports come from only a few foreign countries and if this is a risk.
  • The impact of foreign government subsidies and unfair trade practices on U.S. manufacturers.
  • The economic impact of low prices caused by unfair foreign trade or overproduction.
  • If foreign countries could restrict exports or control supplies, and if this could be used against the U.S.
  • Whether it is possible to increase domestic manufacturing to use fewer imports.
  • The impact of current trade policies and if tariffs or quotas are needed for national security.
  • Whether foreign countries could control or exploit supply chains.
  • If foreign-made PPE, consumables, or equipment could be used to harm the U.S.
  • Any other relevant factors.

Confidentiality and Contact

Business confidential comments will be protected as required by the law. Comments from U.S. Government agencies will not be made public. The BIS website has information and resources at https://efoia.bis.doc.gov/. For help, call (202) 482-0795.

For any more information, contact Stephen Astle, Director, Defense Industrial Base Division, Office of Strategic Industries and Economic Security, BIS, at (202) 482-4506, or visit www.bis.doc.gov/232.

Signed,
Julia A. Khersonsky, Deputy Assistant Secretary for Strategic Trade

Federal Register Vol. 90, No. 185 (September 26, 2025)


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